Targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR): protocol for a randomised controlled trial

BMC Cardiovascular Disorders

Richard J McManus⁷  Bryan Williams²  Jinu Varghese⁴  Helen Shackleford⁴  Claire Schwartz⁴  Cristina Penaloza³  Jonathan Mant⁵  Paul Little¹  Billingsley Kaambwa³  Sue Jowett³  Miren I Jones⁴  FD Richard Hobbs⁷  M Sayeed Haque⁴  Sheila M Greenfield⁴  Stirling Bryan⁶  Emma P Bray⁴  Claire O’Brien⁴ 

[1] School of Medicine, University of Southampton, University Road, Southampton, SO17 1BJ, UK;Institute of Cardiovascular Sciences, University College London, 170 Tottenham Court Road, London, W1T 7HA, UK;Health Economics Unit, School of Health and Population Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK;Primary Care Clinical Sciences, NIHR School for Primary Care Research, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK;Primary Care Unit, Institute of Public Health, University of Cambridge, Forvie Site, Robinson Way, Cambridge, Cambridgeshire, CB1 8RN, UK;Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute, and School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada;Primary Care Health Sciences, NIHR School for Primary Care Research, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK

关键词: Primary care;    Chronic kidney disease;    Coronary heart disease;    Stroke, Diabetes;    Self-management;    Hypertension;   

Others  :  857782
DOI  :  10.1186/1471-2261-13-21

 received in 2013-01-31, accepted in 2013-03-13,  发布年份 2013

【 摘 要 】

Background

Self-monitoring of hypertension with self-titration of antihypertensives (self-management) results in lower systolic blood pressure for at least one year. However, few people in high risk groups have been evaluated to date and previous work suggests a smaller effect size in these groups. This trial therefore aims to assess the added value of self-management in high risk groups over and above usual care.

Methods/Design

The targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR) trial will be a pragmatic primary care based, unblinded, randomised controlled trial of self-management of blood pressure (BP) compared to usual care. Eligible patients will have a history of stroke, coronary heart disease, diabetes or chronic kidney disease and will be recruited from primary care. Participants will be individually randomised to either usual care or self-management. The primary outcome of the trial will be difference in office SBP between intervention and control groups at 12 months adjusted for baseline SBP and covariates. 540 patients will be sufficient to detect a difference in SBP between self-management and usual care of 5 mmHg with 90% power. Secondary outcomes will include self-efficacy, lifestyle behaviours, health-related quality of life and adverse events. An economic analysis will consider both within trial costs and a model extrapolating the results thereafter. A qualitative analysis will gain insights into patients’ views, experiences and decision making processes.

Discussion

The results of the trial will be directly applicable to primary care in the UK. If successful, self-management of blood pressure in people with stroke and other high risk conditions would be applicable to many hundreds of thousands of individuals in the UK and beyond.

Trial Registration

ISRCTN87171227

【 授权许可】

   
2013 O’Brien et al.; licensee BioMed Central Ltd.

【 图 表 】

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